About this trial
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Background:
New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis.
Objectives:
To collect healthy cells from volunteers for research studies for new cancer therapies.
Eligibility:
Healthy people ages 18 and older
Design:
Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample.
Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours.
Participants may donate every 21 days in this protocol if they choose to.
Eligibility criteria
Qualifiers
Age greater than or equal to 18 years old and able to give consent.
Afebrile (temperature less than or equal to 37.5 degree C)
Systolic blood pressure less than or equal to180 mmHg
Diastolic blood pressure less than or equal to100 mmHg
Disqualifiers
History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
Trial design
Treatments tested in this trial
- Not listed